Empagliflozin reduced the risk of cardiovascular death or hospitalization for heart failure and slowed kidney function decline in adults with heart failure with left ventricular ejection fraction (LVEF) over 40% regardless of chronic kidney disease (CKD) status at baseline, according to the results of a prespecified sub-analysis of the EMPEROR-Preserved phase 3 trial. The results were presented at the American Society of Nephrology Kidney Week 2021.
“Heart failure and chronic kidney disease are intimately linked—the risk of death in people with heart failure increases with kidney function decline,” said Faiez Zannad, MD, PhD, emeritus professor of Therapeutics and Cardiology at the University of Lorraine, France, in a press release. “The consistent benefits shown for the reduction of serious heart failure events and the slowing of kidney function decline regardless of chronic kidney disease status are welcome results for both patients and physicians. The findings underscore the potential value of empagliflozin across a wide range of kidney function in this heart failure population that includes people with preserved ejection fraction.”
Nearly half of adults with heart failure also have CKD, which are both associated with high mortality rates and risk for hospital admission. In EMPEROR-Preserved, two-thirds of enrolled adults had heart failure with preserved ejection fraction (HFpEF) and one-third had mildly reduced LVEF. According to the investigators, no currently approved treatments have been clinically proven to significantly improve outcomes across the full spectrum of heart failure.
“Heart failure, especially with preserved ejection fraction, is a complex, difficult-to-treat condition, and the prognosis only worsens with the combined burden of chronic kidney disease,” said Mohamed Eid, MD, MPH, MHA, vice president of Clinical Development & Medical Affairs, Cardio-Metabolism & Respiratory Medicine at Boehringer Ingelheim Pharmaceuticals, Inc, in the release "The encouraging results from this sub-analysis further demonstrate the potential for Jardiance to offer a treatment option for adults with cardio-renal-metabolic conditions.”
According to the prespecified sub-analysis, the benefits seen in the overall population—a significant reduction in risk for cardiovascular death or hospitalization for heart failure in adults with heart failure with LVEF over 40% compared with placebo—were consistent in adults with and without CKD. Empagliflozin improved cardiovascular outcomes and slowed kidney function decline across the full range of kidney function down to an eGFR of 20 mL/min/1.73 m2.
“This data marks an important milestone for the growing number of people living with both heart failure and chronic kidney disease, many of whom are in need of additional treatment options for these interconnected, complex conditions,” said Jeff Emmick, MD, PhD, vice president of Product Development at Lilly, in the release. "We look forward to continuing research with the goal of addressing the unmet needs of those with kidney impairment, including through our EMPA-KIDNEY phase III trial of Jardiance, from which we eagerly await a readout next year.”
Jardiance® shows consistent cardio-renal benefits in adults with heart failure with left ventricular ejection fraction over 40% regardless of chronic kidney disease status [news release]. Lilly; November 5, 2021. Accessed November 5, 2021. https://investor.lilly.com/news-releases/news-release-details/jardiancer-shows-consistent-cardio-renal-benefits-adults-heart